Azithromycin Microspheres in Patients With Low Risk Community Acquired Pneumonia

Phase 3

Completed

• Conditions: Community-Acquired Pneumonia

• Registration Number: NCT00140023
• Lead Sponsor: Pfizer

Brief Summary

The study will assess the clinical efficacy at Day 14-21 (Test of Cure), 14-21 days after starting the study drug; those subjects from whom a baseline pathogen is identified will also be assessed for bacteriologic response. All subjects who receive 1 dose of study medication will be assessed for safety.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-08-29
• Study First Submitted QC: 2005-08-30
• Study First Posted: 2005-08-31
• Study Start: 2005-09
• Study Completion: 2006-06
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-09
• Last Update Posted: 2011-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

• Male or female, 18 years age or older, for whom oral, outpatient therapy is indicated.
• Diagnosis of CAP as manifested by at least 3 or more of the following:
• cough, pleuritic chest pain, fever (temperature of >37.8 C to <40 C), auscultatory findings on pulmonary examination of rales and/or evidence of pulmonary consolidation, dyspnea, tachypnea, laboratory results of elevated total peripheral white blood count (WBC> 10,000/mm3 or greater than 15% immature neutrophils (bands)

Exclusion Criteria

• Known or suspected hypersensitivity or intolerance to azithromycin or other macrolides.
• Previously diagnosed disease(s) of immune function, including: subjects with baseline absolute neutrophil count < 1,000/mm3, HIV positive subjects with CD4 count < 200 cells/mm3, any immunoglobin or neutrophil disorder.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To evaluate the clinical efficacy of 2.0 g single dose of azithromycin microspheres in Low Risk CAP.

Secondary Outcome Measures

Name	Time	Method
To assess bacteriological efficacy of 2.0 g single dose of azithromycin microspheres. To assess the safety and tolerability of 2.0 g single dose of azithromycin microspheres.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇵🇭 Quezon City, Philippines